(Reuters) – The U.S. Food and Drug Administration said on Friday it had approved Stealth Biotherapeutics’ once-daily injection for a rare, genetic disease that primarily affects males, making it the first treatment to be greenlit for the condition.

Stealth’s Forzinity was granted accelerated approval for treating Barth syndrome, in patients weighing at least 30 kg.

Barth syndrome is a rare, serious and life-threatening disease of the mitochondria, the energy-producing parts of cells.

It typically starts with severe heart failure in infancy, and causes premature death. Patients who survive into adolescence and adulthood often have fatigue, poor stamina and exercise intolerance, according to the FDA.

According to a study on the National Institutes of Health’s website, as of 2020, an esti

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